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Completed

NCT Number: NCT02429973

Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.

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Key information

Conditions

Osteosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The trial seeks to analyze progression free survival (PFS), measured as PFS rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). The treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. Gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. Rapamycin is given at 5 mg per day during treatment duration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent signed before any trial test
  • Age equal or less than 80 years
  • Histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression
  • Previous treatment with drugs used in first line: methotrexate, adriamycin, platinum
  • Measurable disease, acoording to RECIST criteria
  • ECOG 0-2

Exclusion criteria

  • Patients who have been irradiated on target lesions
  • ECOG >2
  • Bilirubin levels over normal values. Creatinine over 1.6 mg/dL
  • History of other cancers except basal cell cancer or cervical cancer adequately treated
  • Serious cardiovascular disease

Treatment and study plan

Gemcitabine plus rapamycin

Drug

Gemcitabine and rapamycin given in combination

Primary outcomes

  1. Progression free survival (PFS) rate

    Time frame: 4 months

Secondary outcomes

  1. Tumor response according to RECIST

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Broto, Javier Martín, M.D.

Indiv

Registry information

Official study title

Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Acronym: GEIS-29

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 29, 2015
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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